Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combin
This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby ti
| Condition(s) | Advanced Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC), Metastatic Non Small Cell Lung Cancer, Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to tw |
| Who can participate | Inclusion Criteria: * 18 years of age or older at screening. * Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system). * Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy * PD-L1 status available based on local testing results * Measurable disease based on RECIST v1.1 per investigator. * Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1 * Expected survival ≥12 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Pfizer |
| Locations | Bullhead City, Arizona, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States (+340 more sites) |
| Start date | 2026-01-06 |
| NCT ID | NCT07222566 |
| Official listing | https://clinicaltrials.gov/study/NCT07222566 |